Performance Characteristics for Some Typical QT Study Designs Under the ICH E-14 Guidance
Author:
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Reference8 articles.
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2. Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use E14 guideline;Darpo;J Clin Pharmacol.,2006
3. Investigating drug-induced QT and QTc prolongation in the clinic: a review of statistical design and analysis considerations. Report from the pharmaceutical research and manufacturers of America QT statistics expert team;Pharmaceutical Research and Manufacturers of America QT Statistics Expert Working Team;Drug Inf J.,2005
4. Assessment of equivalence on multiple endpoints;Quan;Stat Med.,2001
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